By 2020, China is expected to be the second largest pharmaceutical market in the world, but for smaller biotech companies with fewer than three drugs, bringing products to market can be challenging, panelists at the BIO CEO and Investor Conference in New York said on Monday.
The average time to bring a drug to market in China, even if it's already approved in the US or EU, can range from five to seven years.
Friedhelm Blobel, president and CEO of SciClone Pharmaceuticals, said the most straight-forward way to get a developing drug onto the Chinese market is to add between two and three clinical trial sites in China at the end of a Phase II trial.
He said adding clinical sites in China before conducting a Phase 3 trial can save about three years in the development process. But it’s “almost impossible” to bring products to market without local partners and the Chinese State Food and Drug Administration (SFDA) looks down on multi-national Western companies attempting to conduct Phase I trials there.
Blobel gave the example of the partnership between Chinese contract research organisation (CRO) Wuxi and AstraZeneca as a successful model.
Jimmy Zhang of Merck was of a similar opinion, warning that if companies wait until Phase 3 to introduce their drugs in China, they might have to start from scratch with a Phase I trial conducted through a local partner.
This he suggested is why most investments by multi-national pharmaceutical companies in China are in CROs.
Kewen Jin, managing director of Nimbus Innoworks agreed, suggesting that small biotechs should “find a trustworthy partner and let them do all the heavy lifting.”
Invest in China?
But while investing in CROs may benefit sponsors, western contractors hoping to win a share of Chinese market should think twice according to Jin, who set up one of the country’s first research firms – BioExplorer – and has worked locally for Charles River Labs.
Jin said the early stages of explosive growth from the early 2000s are gone, adding that it’s “not a good time to start a CRO in China.”